[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433020":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":19,"collaborators":10,"id":21,"slug":10,"hasResults":22,"nctId":23,"briefTitle":24,"officialTitle":25,"acronym":10,"eligibilityCriteria":26,"healthyVolunteers":27,"sex":28,"minAge":29,"maxAge":30,"enrollmentInfo":31,"targetDuration":10,"studyType":34,"phases":10,"briefSummary":35,"conditions":36,"keywords":10,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":10},{"fullName":5,"class":6},"Implantcast North America, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EcoFit® Total Hip System with implacross® E Polyethylene",null,"Subjects who meet the indications for use for the EcoFit® Total Hip System with implacross® E Polyethylene and are candidates for a primary hip replacement.",[13],"Device: EcoFit® Total Hip System with implacross® E Polyethylene",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","The EcoFit® Total Hip System is a primary hip replacement system indicated for patients who are candidates for a primary cementless hip replacement. implacross® E Polyethylene is one of the components in the EcoFit® system.",[9],{"type":20,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100433020",false,"NCT04918680","Prospective Post-market Study Examining the Effectiveness of the EcoFit®","Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene","Inclusion Criteria:\n\n* Subject must be a candidate for a total primary hip replacement.\n* Subject must have degenerative joint disease, including osteoarthritis or traumatic arthritis, OR a femoral fracture which can be treated by a primary hip replacement and no other hardware\n* Subject has a BMI of 40.00 kg\u002Fm2 or less at the time of enrollment\n* Subject is likely to be available for evaluation for the duration of the study\n* Subject is able and willing to sign the informed consent and follow study procedures\n* Subject is not pregnant\n\nExclusion Criteria:\n\n* Subject has had a prior hip replacement in the subject hip\n* Subject has an active cancer or is a survivor for \\\u003C5 years except for squamous cell or basal cell skin cancer\n* Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol\n* Subject is currently a documented substance abuser (alcohol or other addictions)\n* Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic\n* Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity\n* Subject has a BMI \\> 40.00 kg\u002Fm2\n* Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)\n* Subject is a prisoner\n* Subject is pregnant\n* Subject has known materials sensitivity (to metals)",true,"ALL","40 Years","75 Years",{"count":32,"type":33},500,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.",[37,38,39,40],"Degenerative Joint Disease","Femoral Fracture","Osteoarthritis, Hip","Traumatic Arthritis","NOT_YET_RECRUITING","2021-06-01",{"date":44,"type":45},"2021-06-09","ACTUAL",{"date":47,"type":33},"2021-06-21",{"date":49,"type":33},"2027-03-30",{"name":5,"class":6}]